Lower Extremity AmputationNCT03592316
Impact of a Lower Extremity Amputation Pathway Protocol in Dysvascular Patients
A study testing Lower Extremity Amputation Pathway in people with Lower Extremity Amputation, run by University of California, San Francisco at 1 site in United States.
Trial summary
The LEAP protocol is a prospective cohort study of dysvascular patients designed to determine whether implementation of a multi-disciplinary lower extremity amputation protocol in the peri-operative period can shorten post-operative length of stay in patients undergoing trans-tibial or trans-femoral amputations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Extremity Amputation
- What is being tested?
- Lower Extremity Amputation Pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients >18 years of age diagnosed with peripheral vascular disease and/or diabetes mellitus
- Patients undergoing trans-tibial or trans-femoral amputations
Who cannot join
- Patients undergoing amputation for trauma, malignancy, or necrotizing fasciitis with no dysvascular diagnosis
- Patients who have previously undergone an amputation
- Patients who were unable to function independently prior to admission
- Patients admitted to the ICU prior to surgery
- Attending surgeon does not approve of the patient being enrolled
- Prisoners
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Community Regional Medical Center
Fresno, California, 93721
About this study
The LEAP protocol is a prospective cohort study of dysvascular patients designed to determine whether implementation of a multi-disciplinary lower extremity amputation protocol in the peri-operative period can shorten post-operative length of stay in patients undergoing trans-tibial or trans-femoral amputations. A consecutive sample of patients diagnosed with peripheral vascular disease and/or diabetes requiring major lower extremity amputation will be enrolled in the study and compared to retrospective controls.
- Conditions
- Lower Extremity Amputation
- Being tested
- Lower Extremity Amputation Pathway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower Extremity Amputation PathwayOther
Pre-operatively: Subjects will meet with social work/case management, physical therapy, anesthesiology, and the prosthetist for the following: discuss expectations and rehabilitation; pain control options and consideration for epidural or nerve block; prosthetic treatment and care timeline.
Post-operatively: Physical therapy will begin on post-op day 1 with increasing complexity through post-op day 3. On post-op day 3 the wound will be examined by the surgeon and subjects will be cleared for discharge.
Quality of life surveys will be given at several time points during post-operative care.
| Study group | Role | What they receive |
|---|---|---|
| Lower Extremity Amputation Pathway | Experimental | Patients will follow the Lower Extremity Amputation Pathway, which will include pre-operative consultations and earlier progression with physical therapy post-operatively. Receives: Other: Lower Extremity Amputation Pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital length of stay
The total hospital length of stay for the lower extremity amputation admission
Measured: Through hospital discharge, approximately 3 days after surgery
Secondary outcomes (4)
Mortality
Mortality during the follow-up period
Measured: Up to 6 months after surgery
Major adverse limb event
Hematoma, infection, ischemia, and/or need for revision of amputation
Measured: Up to 6 months after surgery
In-hospital morbidity
Catheter Associated Urinary Tract Infection, Pneumonia, Deep Vein Thrmbosis, and/or Pulmonary Embolism
Measured: Through hospital discharge, approximately 3 days after surgery
Return to functional independence
Time to return to functional independence at home
Measured: Up to 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start14 Nov 2018
- Primary completion31 Mar 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity AmputationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leigh Ann O'Banion, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592316
- Sponsor's protocol ID
- 2018021
- Status last verified
- Feb 2021
- First submitted
- 10 Jul 2018
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Lower Extremity Amputation Pathway Protocol in Dysvascular Patients
- ClinicalTrials.gov ID
- NCT03592316
- Acronym / sponsor ID
- 2018021
- Conditions
- Lower Extremity Amputation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 19 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The LEAP protocol is a prospective cohort study of dysvascular patients designed to determine whether implementation of a multi-disciplinary lower extremity amputation protocol in the peri-operative period can shorten post-operative length of stay in patients undergoing trans-tibial or trans-femoral amputations. A consecutive sample of patients diagnosed with peripheral vascular disease and/or diabetes requiring major lower extremity amputation will be enrolled in the study and compared to retrospective controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lower Extremity Amputation Pathway | Experimental | Other: Lower Extremity Amputation PathwayPatients will follow the Lower Extremity Amputation Pathway, which will include pre-operative consultations and earlier progression with physical therapy post-operatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients >18 years of age diagnosed with peripheral vascular disease and/or diabetes mellitus
- Patients undergoing trans-tibial or trans-femoral amputations
Key exclusion criteria (7 listed)
- Patients undergoing amputation for trauma, malignancy, or necrotizing fasciitis with no dysvascular diagnosis
- Patients who have previously undergone an amputation
- Patients who were unable to function independently prior to admission
- Patients admitted to the ICU prior to surgery
- Attending surgeon does not approve of the patient being enrolled
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lower Extremity Amputation PathwayPre-operatively: Subjects will meet with social work/case management, physical therapy, anesthesiology, and the prosthetist for the following: discuss expectations and rehabilitation; pain control options and consideration for epidural or nerve block; prosthetic treatment and care timeline. Post-operatively: Physical therapy will begin on post-op day 1 with increasing complexity through post-op day 3. On post-op day 3 the wound will be examined by the surgeon and subjects will be cleared for discharge. Quality of life surveys will be given at several time points during post-operative care. | Other | Lower Extremity Amputation Pathway |
Primary outcome
Hospital length of stay
Time frame: Through hospital discharge, approximately 3 days after surgery
The total hospital length of stay for the lower extremity amputation admission
4 secondary outcomes
Mortality
Time frame: Up to 6 months after surgery
Major adverse limb event
Time frame: Up to 6 months after surgery
In-hospital morbidity
Time frame: Through hospital discharge, approximately 3 days after surgery
Return to functional independence
Time frame: Up to 6 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leigh Ann O'Banion, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lower Extremity Amputation Pathway in people with Lower Extremity Amputation, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital length of stay (time frame: Through hospital discharge, approximately 3 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021.